Complex Adult Deformity Surgery (CADS) Study
This study is looking at the results of surgery for complex adult spinal deformities like scoliosis (a sideways curve of the spine) and kyphosis (a rounded back). It aims to understand how well these surgeries work and to find the best ways to treat patients. Researchers will collect information on your health before and after surgery, including how your spine looks on X-rays and how your pain and daily activities are affected. They will also look at any complications and the need for additional surgeries. This study is for adults aged 18 and older who have a diagnosis of adult spinal deformity and meet certain criteria for complex cases. The study is currently unclear on its recruitment status and plans to enroll 1500 participants.
- Study design
- This is an observational study, meaning researchers will collect information about your surgery and recovery without assigning you to a specific treatment. It plans to include 1500 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health and spine will be checked at 3 months, and then at 1, 2, 5, and 10 years after your surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Complex Adult Deformity Surgery (CADS)
At a glance
Conditions
NCT04194138
Where you'd take part
This study runs at 18 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Columbia University Medical Center
New York, New Yorkstudy coordinator listed
Recruiting
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
Denver, Coloradostudy coordinator listed
Recruiting
Duke University Health System
Durham, North Carolinastudy coordinator listed
Recruiting
Hospital for Special Surgery, Department of Orthopedic Surgery
New York, New Yorkstudy coordinator listed
Recruiting
John Hopkins University, Department of Orthopedic Surgery
Baltimore, Marylandstudy coordinator listed
Recruiting
Medical City Spine Hospital - Southwest Scoliosis Institute
Dallas, Texasstudy coordinator listed
Recruiting
Northwell Health
New York, New Yorkstudy coordinator listed
Recruiting
Norton Leatherman Spine Center
Louisville, Kentuckystudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Shay Bess, MD · PRINCIPAL_INVESTIGATOR
- Lawrence Lenke, MD · PRINCIPAL_INVESTIGATOR · Columbia University, Department of Orthopedic Surgery
- Christopher Shaffrey, MD · PRINCIPAL_INVESTIGATOR · Duke University, Departments of Neurosurgery and Orthopaedic Surgery
Who to contact
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Inclusion
What this trial measures
- Scoliosis Research Society (SRS) 22rChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Scoliosis specific patient reported outcome
- Oswestry Disability Index (ODI)Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Spine specific patient reported outcome
- Veterans RAND 12 Item Health Survey (VR-12)Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Patient reported outcome
- Radiographic EvaluationChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Cobb angles, Coronal \& Sagittal balance, spinopelvic measures
- Patient-Reported Outcome Measurement Information System (PROMIS) - AnxietyChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PROs
- Patient-Reported Outcome Measurement Information System (PROMIS) - DepressionChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PRO
- Patient-Reported Outcome Measurement Information System (PROMIS) - Pain InterferenceChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PRO
- Patient-Reported Outcome Measurement Information System (PROMIS) - Physical FunctionChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PRO
- Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role SatisfactionChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PRO
- Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA)Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PRO
- Visual Analog Scale - Back PainChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Self-reported back pain on scale of 0 (No pain) to 10 (severe pain)
- Visual Analog Scale - Leg PainChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Self-reported leg pain on scale of 0 (No pain) to 10 (severe pain)